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Fluticasone gets rid of eosinophils in the esophagus, but does not improve symptoms

A group of Mayo Clinic researchers conducted the first controlled trial of swallowed fluticasone nasal spray (also known as Flonase) on people with the allergic esophageal condition called eosinophilic esophagitis. Research showed that the aerosolized swallowed allergy drug helped treat the cause of the throat condition, but symptoms lingered. The researchers' findings were presented today at the Annual Scientific Meeting of the American College of Gastroenterology in San Antonio.

18 Oct 2010

Hyperion's HPN-100 granted FDA Fast Track Designation for urea cycle disorders

Hyperion Therapeutics, Inc. announced today that its investigational compound glycerol phenylbutyrate (HPN-100) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as adjunctive therapy for the chronic management of urea cycle disorders. Hyperion recently completed its phase III trial which was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The Company plans to announce results from that trial later this year.

18 Oct 2010

FDA grants fast track designation for Aastrom's CLI cell therapy development program

Aastrom Biosciences, Inc., a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted fast track designation for the company's critical limb ischemia (CLI) cell therapy development program. Aastrom plans to initiate Phase 3 clinical testing of its treatment for CLI in early 2011.

18 Oct 2010

14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

Eli Lilly and Company today announced that a total of 14 U.S. and global studies involving its osteoporosis medications, FORTEO® [teriparatide (rDNA origin) injection] and EVISTA® (raloxifene HCl tablets), will be presented at the American Society for Bone and Mineral Research (ASBMR) 2010 Annual Meeting from October 15-19 in Toronto, ON, Canada.

18 Oct 2010

BioSante enrolls 2,500th woman in LibiGel Phase III cardiovascular and breast cancer safety study

BioSante Pharmaceuticals, Inc. today announced enrollment of the 2,500th woman in the LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. This important enrollment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events.

18 Oct 2010

EC grants orphan drug designation to S*BIO's SB1518 for treatment of myelofibrosis

S*BIO Pte Ltd today announced that the European Commission (EC) has granted orphan drug designation to SB1518, its potent and orally active JAK2 inhibitor for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). SB1518 has also received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of the same disorder.

18 Oct 2010

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

NovaBay Pharmaceuticals, Inc. announced today that its development partner, Alcon Research, Ltd., has concluded its proof of concept clinical trial of NovaBay's patented lead Aganocide compound, NVC-422 for the treatment of viral conjunctivitis a highly contagious eye infection for which there are currently no marketed products.

18 Oct 2010

Nektar presents data of NKTR-181 mu-opioid analgesic candidate at Pain 2010 Symposium

Nektar Therapeutics presented promising data today from preclinical studies of NKTR-181, a next-generation mu-opioid analgesic candidate with a novel molecular design. NKTR-181 is being developed to effectively treat pain while addressing the abuse liability and serious side effects associated with traditional opioid therapies.

18 Oct 2010

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

Tranzyme Pharma announced today that John Wo, MD, Professor of Medicine and Director, Clinical Research, Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, KY, will present preliminary TZP-102 Phase 2 data at this year's ACG annual meeting. The event is being held at the Henry B. Gonzalez Convention Center in San Antonio TX, October 15-20, 2010. Professor Wo is scheduled to speak on Wednesday, October 20th at 8:50am in Ballroom C1.

18 Oct 2010

Cempra to present data on solithromycin, TAKSTA at 48th Annual Meeting in Vancouver

Cempra Pharmaceuticals today announced poster presentations on its novel fluoroketolide antibiotic, solithromycin (CEM-101), and the Company's proprietary front-loading oral dosing regimen of sodium fusidate, TAKSTA (CEM-102) at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.

18 Oct 2010

Nektar presents NKTR-181 preclinical data at ASA 2010 Annual Meeting

Nektar Therapeutics today presented new preclinical data demonstrating that NKTR-181, a mu-opioid analgesic with a novel molecular structure, dramatically reduces abuse liability while providing analgesia comparable to oxycodone and morphine.

18 Oct 2010

PTC announces ataluren Phase 2b efficacy data at International Congress

PTC Therapeutics, Inc. today announced that final analyses of Phase 2b efficacy data suggest the investigational new drug ataluren slowed the loss of walking ability in patients with nonsense mutation dystrophinopathy, a disease continuum comprising Duchenne and Becker muscular dystrophy (nmDBMD). These data were presented at the International Congress of the World Muscle Society in Kumamoto, Japan and will be the basis of interactions with the U.S. Food and Drug Administration (FDA) and national regulatory authorities in Europe in the fourth quarter of 2010.

18 Oct 2010

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

18 Oct 2010

Teva Pharmaceutical announces new data from PreCISe study

Teva Pharmaceutical Industries Ltd. today announced new data from the five-year extension of the PreCISe study demonstrating that earlier initiation of treatment with Copaxone (glatiramer acetate injection) in patients presenting with first signs of multiple sclerosis (MS), provided greater effects in delaying conversion to clinically definite MS (CDMS) compared to later treatment initiation after diagnosis of CDMS or after three years on the study.

18 Oct 2010

Neuroprotective properties of laquinimod for RRMS presented at 26th ECTRIMS Congress

Teva Pharmaceutical Industries Ltd. and Active Biotech announced today that data providing further evidence of the neuroprotective properties of laquinimod in animal studies were presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden.

15 Oct 2010

EC grants orphan medicinal product designation to Allos' pralatrexate for Hodgkin lymphoma

Allos Therapeutics, Inc. announced today that the European Commission (EC) has granted orphan medicinal product designation for pralatrexate for the treatment of Hodgkin lymphoma (HL). The Company is currently investigating pralatrexate in a number of ongoing studies, including a Phase 2 clinical study in patients with relapsed or refractory non-Hodgkin lymphoma or Hodgkin lymphoma.

15 Oct 2010

Genentech and Biogen Idec announce positive results from ocrelizumab phase II RRMS study

Genentech, Inc., a member of the Roche Group, and Biogen Idec today announced 24-week results from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate.

15 Oct 2010

Oseltamivir reduces mortality in influenza A/H5N1 patients

A study published in the Journal of Infectious Diseases indicates that treatment with oseltamivir significantly reduces mortality in patients with influenza A/H5N1, or 'bird flu', even when given late in the course of illness.

15 Oct 2010

Enrollment complete in Inhibitex's FV-100 Phase II clinical trial in shingles patients

Inhibitex, Inc., announced today that it has completed enrollment in a Phase II clinical trial of FV-100 in shingles (herpes zoster) patients. The objectives of the trial are to further evaluate the safety of FV-100 and its potential therapeutic benefit in reducing the severity and duration of shingles-associated pain, the incidence of post herpetic neuralgia (PHN), and the time to heal shingles-related lesions.

15 Oct 2010

NovaBay to present two poster presentations at IDSA Annual Meeting

NovaBay Pharmaceuticals, Inc. a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces that it will deliver two poster presentations on its compounds at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA).

15 Oct 2010

Drug Trial News

Fluticasone gets rid of eosinophils in the esophagus, but does not improve symptoms

Hyperion's HPN-100 granted FDA Fast Track Designation for urea cycle disorders

FDA grants fast track designation for Aastrom's CLI cell therapy development program

14 global studies on osteoporosis medications FORTEO and EVISTA to be presented at ASBMR 2010

BioSante enrolls 2,500th woman in LibiGel Phase III cardiovascular and breast cancer safety study

EC grants orphan drug designation to S*BIO's SB1518 for treatment of myelofibrosis

Alcon concludes 'proof of concept' clinical trial of NovaBay's Aganocide for viral conjunctivitis treatment

Nektar presents data of NKTR-181 mu-opioid analgesic candidate at Pain 2010 Symposium

Preliminary Phase 2 data of TZP-102 for diabetic gastroparesis to be presented at ACG annual meeting

Cempra to present data on solithromycin, TAKSTA at 48th Annual Meeting in Vancouver

Nektar presents NKTR-181 preclinical data at ASA 2010 Annual Meeting

PTC announces ataluren Phase 2b efficacy data at International Congress

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Teva Pharmaceutical announces new data from PreCISe study

Neuroprotective properties of laquinimod for RRMS presented at 26th ECTRIMS Congress

EC grants orphan medicinal product designation to Allos' pralatrexate for Hodgkin lymphoma

Genentech and Biogen Idec announce positive results from ocrelizumab phase II RRMS study

Oseltamivir reduces mortality in influenza A/H5N1 patients

Enrollment complete in Inhibitex's FV-100 Phase II clinical trial in shingles patients

NovaBay to present two poster presentations at IDSA Annual Meeting

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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